Status:
UNKNOWN
Transplantation of Bone Marrow Stem Cells Stimulated by Proteins Scaffold to Heal Defects Articular Cartilage of the Knee
Lead Sponsor:
Michel Assor, MD
Conditions:
Osteoarthritis
Knee Osteoarthritis
Eligibility:
All Genders
30-75 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this pilot study is to investigate the efficacy and safety of autologous transplantation, under arthroscopy, of Bone Marrow Mesenchymal stem cells, using, with a cell separator, a fresh...
Detailed Description
Before the implantation of the mesenchymal stem cells, a knee arthroscopy procedure is made for the debridement of the meniscal and cartilage lesions, with microperforation and abrasion, preparation o...
Eligibility Criteria
Inclusion
- Active patients (30 to 75 years)
- A localized osteochondral defect of both condyle and/or tibia grade 4 (ICRS classification)
- with cartilage on the tibial surface no more than grade 3-4, of size \< 3-4 cm2, with 3/4 of meniscus present.
- Stable knee ; previous ligament reconstruction, if stable
- A defect that is 1 - 4 cm2 or more, up to 6 cm2, located on the femoral condyle and /or less of 4 cm2 for tibial plate, and IKS score \<75.
- Kissing lesions admitted
- Ability to understand and willingness to sign consent form
Exclusion
- Patients younger than 30 years and older than 75 years
- Diffuse and advanced articular cartilage degeneration of the joint
- Axial malalignment, meniscal pathology, and ligamentous instability are relative contraindications that have to be dealt with primarily either concomitantly or before the transplantation during 1 of the 2 stages of the procedure. Refusal of the patient to address these conditions in presence of a cartilage lesion is a criterion for exclusion from the study, to avoid the impact of these knee pathologies on the final results
- Existing infection in or around the joint \& lesions of infectious or oncologic etiology.
- Debilitated patients.
- Immunocompromised patients.
- Patients with autoimmune disorders \& systemic inflammatory disease.
- Preoperative poor neurological or vascular status of the affected limb.
- Specific contraindications include the use of tobacco and medications that may impair cell proliferation, such as NSAIDs and immunosuppressive drugs. Patients must be nicotine-free (stop smoking) prior to the procedure, as studies have shown that the oxidative effect of smoking impairs cell function and subsequent healing.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01159899
Start Date
July 1 2010
End Date
December 1 2014
Last Update
January 8 2013
Active Locations (1)
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1
Knee and Lower Limb Institute, Dr Michel Assor
Marseille, France, 13008